The Clinical Research Management Office (CRMO) is the shared resource for the conduct of clinical research at the LCC. The functions of the CRMO are to facilitate the conduct of clinical research by maintaining the infrastructure support for clinical researchers and providing an interface with regulatory and sponsoring agencies. The Director of the CRMO, Edward P. Gelmann, M.D., has extensive experience in administration and is active in the conduct of clinical research. The CRMO has five offices, Research Nursing, Data Management, Research Operations, Protocol Office, and Clinical Research Database. An experienced senior individual who reports to the Director of the CRMO heads each division. The Research Nursing Office is responsible for the assignment, supervision, and training of 10 research nurses who staff the LCC clinical trials. The Data Management Office is responsible for the assignment, supervision, and training of 11 data managers. The Supervisor of Data Management also is responsible for audit compliance and quality assurance. The Protocol Office with a supervisor and a staff of five, maintains files on each protocol submitted to the CRMO, submits protocols, amendments, annual reviews and adverse drug reaction reports to the IRB and LCC's Protocol Review and Monitoring Committee, the Clinical Research Committee (CRC) and maintains current copies of open protocols on a password protected website for investigators and staff. The Research Operations Office is responsible for oversight of quality control of the CRMO and implementation of new procedures. The Clinical Research Database is an Oracle-based system that contains protocol entry and exit information and demographic data on each patient who enters a clinical protocol, electronically downloads data from the Georgetown Hospital SMS Information System, and is the repository for all data for LCC single institution trials. The CRMO works closely with the CRC, investigators, the Biostatistics Shared Resource, and the Cancer and Leukemia Group to bring efficient, seamless and responsible clinical trials management to the LCC.